Commonwealth Numbered Regulations - Explanatory Statements

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NATIONAL HEALTH AMENDMENT REGULATIONS 2011 (NO. 1) (SLI NO 169 OF 2011)

EXPLANATORY STATEMENT

Select Legislative Instrument 2011 No. 169

National Health Act 1953

National Health Amendment Regulations 2011 (No. 1)

Section 140 of the National Health Act 1953 (the Act) provides, in part, that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which by the Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act.

Paragraph 9A(1)(a) of the Act provides that the Minister for Health and Ageing (the Minister) may, on behalf of the Commonwealth Government, arrange for the supply by the Commonwealth of 'such medical or surgical aids, equipment or appliances as are prescribed to persons who require them'.  'Prescribed' means prescribed under the Regulations to the Act.

Subsection 9A(3) of the Act provides that the Minister may impose such conditions as the Minister thinks fit on the use or possession of aids, equipment or appliances supplied, or to be supplied, under subsection 9A(1) of the Act. 

Regulation 42 of the National Health Regulations 1954 (the Principal Regulations) provides that the medical or surgical aids, equipment and appliances specified in Schedule 1 to the Principal Regulations are prescribed for the purposes of paragraph 9A(1)(a) of the Act.

The purpose of the Regulations is to amend current eligibility restrictions for access to syringes and needles through the National Diabetes Services Scheme (NDSS) for the purposes of paragraph 9A(1)(a) of the Act.

The Regulations ensure that NDSS registrants who are prescribed injectable non insulin blood glucose lowering medications, are able to access subsidised syringes and needles for the delivery of their medication. This implements an outcome of the 2011-12 Commonwealth Budget.

The relevant items in the Principal Regulations may not cover insulin pump consumables, which were added to the NDSS in 2004.  The Principal Regulations therefore are amended to cover insulin pump consumables more clearly.

The NDSS aims to ensure that people with diabetes have timely, reliable and affordable access to products and services that help them effectively self-manage their condition.

Details of the Regulations are set out in the Attachment.

The Act specifies no conditions that need to be met before the power to make the  Regulations may be exercised.

The Regulations are a legislative instrument for the purposes of the Legislative Instrument Act 2003.

The Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.

Consultation

Pharmaceutical company Eli Lilly listed a new injectable non insulin blood glucose lowering medication on the Pharmaceutical Benefits Scheme from 1 August 2010.  Eli Lilly then applied to the Department of Health and Ageing to extend National Diabetes Services Scheme (NDSS) eligibility criteria to allow people with diabetes who are registered on the NDSS, access to syringes and needles to administer this new medication.  Eli Lilly has been consulted during this process and kept informed of updates in their application process.

Diabetes Australia Ltd (DAL) administers the NDSS on behalf of the Department of Health and Ageing.  DAL has been consulted regarding amendments that need to be made to the NDSS IT system to allow access to syringes and needles for NDSS registrants with type 2 diabetes who are prescribed injectable non-insulin blood glucose lowering medications.

ATTACHMENT

Details of the National Health Amendment Regulations 2011 (No. 1)

Regulation 1 - Name of Regulations

This regulation provides that the title of the Regulations is the National Health Amendment Regulations 2011 (No. 1).

Regulation 2 - Commencement

This regulation provides for the Regulations to commence on the day after they are registered.

Regulation 3 - Amendment of the National Health Regulations 1954

This regulation provides that the National Health Regulations 1954 (the Principal Regulations) are amended as set out in Schedule 1.

Schedule 1 - Amendments

Item [1] - Subregulation 2(1), before the definition of approved form

This item defines Act as the National Health Act 1953 as a consequence of the change in item [3].

Item [2] - Subregulation 2(1), after the definition of approved form

This item defines 'insulin pump consumables' as the equipment manufactured for use with an insulin pump.  This equipment includes cannulae, tubing, insulin reservoirs and insulin cartridges, other than insulin cartridges that contain insulin when the cartridges are supplied.  This definition is needed to limit 'insulin pump consumables' to the products currently supplied under this category through the National Diabetes Services Scheme (the NDSS).  There are many products that could be described as insulin pump consumables which are not supplied through the NDSS.

Item [3] - Subregulation 2(1), definition of the Act

This item removes the terminology the Act and replaces it with Act in reference to the National Health Act 1953.  This change was recommended by the Office of Legislative Drafting and Publishing as a minor technical correction to the wording of the Regulations.

Item [4] - Schedule 1, after item 17

This item inserts an item to prescribe needles for the delivery of injectable blood glucose lowering medications other than insulin.  It also adds an item to prescribe insulin pump consumables as it was identified that the items in the Principal Regulations may not cover insulin pump consumables, which were added to the NDSS in 2004 following a new policy proposal.

Item [5] - Schedule 1, after the table

This item inserts a note after the table referring readers to subregulation 2(1) for the definition of insulin pump consumables.

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